GaltTWS

FDA registration

GALT MEDICAL CORP.·3 products·🇺🇸 United States

PressureWire X

FDA registration

ABBOTT VASCULAR·3 products·🇺🇸 United States

Wire, guide, catheterTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCYTRANSDUCER, PRESSURE, CATHETER TIP

FDA registration

SUZHOU PROSTERI MEDICAL TECHNOLOGY CO., LTD.·3 products·🇨🇳 China

Metal Craft Machine & Engineering, Inc.

FDA registration

Metal Craft Machine & Engineering, Inc.·3 products·🇺🇸 United States

transducer, pressure, catheter tip

FDA registration

SHANGHAI JPY ION-TECH CO., LTD.·3 products·🇨🇳 China

PressureWire X

FDA registration

Abbott Medical·3 products·🇺🇸 United States

Stainless Steel Angiography Guide Wires

FDA registration

Sterigenics Belgium Petit Rechain S.A.·3 products·🇧🇪 Belgium

AltaTrack equipment R1

FDA registration

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·3 products·🇳🇱 Netherlands

St. Jude Medical, Atrial Fibrillation Division, Inc.

FDA registration

St. Jude Medical, Atrial Fibrillation Division, Inc.·3 products·🇺🇸 United States

Stainless Steel Angiography Guide Wires

FDA registration

Sterigenics U.S. LLC·3 products·🇺🇸 United States

transducer, pressure, catheter tip

FDA registration

SHANGHAI JPY ION-TECH CO., LTD.·3 products·🇨🇳 China

PressureWire Certus and Aeris

FDA registration

St. Jude Medical, Cardiology Division, Inc.·3 products·🇺🇸 United States

AltaTrack Guidewire

FDA registration

Volcano Corporation·3 products·🇺🇸 United States

Sterigenics EO Canada, Inc.

FDA registration

Sterigenics EO Canada, Inc.·3 products·🇨🇦 Canada

SavvyWire

FDA registration

OPSENS INC.·3 products·🇨🇦 Canada

GaltTWS

FDA registration

Theragenics Costa Rica Limitada·3 products·🇨🇷 Costa Rica

IQX GmbH

Authorized representative

🇦🇹 Austria·1 Manufacturer·12 Devices

015-00-00-MDR

Certificate

MDR QMS·ATENA LUX S.R.L.·ITALCERT SRL

074-02-02-DM

Certificate

MDD Annex II (excluding section 4)·ATENA LUX S.R.L.·ITALCERT SRL·28 Basic UDI-DIs

074-02-03

Certificate

MDD Annex II (excluding section 4)·ATENA LUX S.R.L.·ITALCERT SRL·1 Basic UDI-DI